ACTRN12613000843752
Not yet recruiting
Phase 4
In patients with type 2 diabetes as opposed to healthy volunteers, what will the GLP-1 release and expression of glucose sensing molecules be in functionally identified colonic cells, activated by glucose or glibenclamide
Dr. Nam Q Nguyen0 sites40 target enrollmentJuly 31, 2013
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Type II Diabetes
- Sponsor
- Dr. Nam Q Nguyen
- Enrollment
- 40
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with type 2 diabetes (World Health Organisation (WHO) criteria) managed by diet alone or metformin, with a HbA1c \=/\< 7\.5%.
- •Healthy volunteers, matched as closely as possible to the diabetic subjects for age, sex, and body mass index.
Exclusion Criteria
- •Significant illness other than diabetes, including impairment to cardiovascular or respiratory function that limits a subject’s activity and therefore would represent a risk to undertaking endoscopy safely (American Society of Anesthesiologists Grade 3 or more)
- •History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms (as assessed by a validated upper gastrointestinal symptom questionnaire, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
- •Haemoglobin below the lower limit of the normal range (ie. \<135g/L for men and 115g/L for women), and ferritin below the lower limit of normal (ie. \<10mcg/L)
- •Impaired renal or liver function (as assessed by calculated creatinine clearance \< 90 mL/min or abnormal liver function tests (\> 2 times upper limit of normal))
- •History of severe respiratory, cardiovascular, hepatic and/or renal disease, chronic alcohol abuse or epilepsy (excluded by history)
- •Subjects requiring medication that may influence gastrointestinal function
- •Any patient with coagulopathy.
- •Allergy to glibencamide and/or sulphonamide derivatives
- •Patients with Thrombocytopenia
- •Patients requiring treatment with anticoagulants, anti\-platelet agents and NSAIDS
Outcomes
Primary Outcomes
Not specified
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